BILL NUMBER: AB 1215	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Hagman

                        FEBRUARY 22, 2013

   An act to amend Section 1209 of the Business and Professions Code,
relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1215, as introduced, Hagman. Clinical laboratories.
   Existing law provides for the licensure, registration, and
regulation of clinical laboratories and various clinical laboratory
personnel by the State Department of Public Health. Existing law
prohibits the performance of a clinical laboratory test or
examination classified as waived under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA) unless the test or
examination is performed under the overall operation and
administration of a laboratory director. Existing law defines
"laboratory director", for purposes of a clinical laboratory test or
examination classified as waived, as an individual who, among others,
is a duly licensed naturopathic doctor.
   This bill would expand the definition of "laboratory director" for
purposes of a clinical laboratory test or examination classified as
waived to include a duly licensed clinical laboratory scientist.
   Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 1209 of the Business and Professions Code is
amended to read:
   1209.  (a) As used in this chapter, "laboratory director" means
any person who is a duly licensed physician and surgeon, or, only for
purposes of a clinical laboratory test or examination classified as
waived, is  a duly licensed clinical laboratory scientist, 
a duly licensed naturopathic doctor, or a duly licensed optometrist
serving as the director of a laboratory which only performs clinical
laboratory tests authorized in paragraph (10) of subdivision (e) of
Section 3041 that are classified as waived, or is licensed to direct
a clinical laboratory under this chapter and who substantially meets
the laboratory director qualifications under CLIA for the type and
complexity of tests being offered by the laboratory. The laboratory
director, if qualified under CLIA, may perform the duties of the
technical consultant, technical supervisor, clinical consultant,
general supervisor, and testing personnel, or delegate these
responsibilities to persons qualified under CLIA. If the laboratory
director reapportions performance of those responsibilities or
duties, he or she shall remain responsible for ensuring that all
those duties and responsibilities are properly performed.
   (b) (1) The laboratory director is responsible for the overall
operation and administration of the clinical laboratory, including
administering the technical and scientific operation of a clinical
laboratory, the selection and supervision of procedures, the
reporting of results, and active participation in its operations to
the extent necessary to ensure compliance with this act and CLIA. He
or she shall be responsible for the proper performance of all
laboratory work of all subordinates and shall employ a sufficient
number of laboratory personnel with the appropriate education and
either experience or training to provide appropriate consultation,
properly supervise and accurately perform tests, and report test
results in accordance with the personnel qualifications, duties, and
responsibilities described in CLIA and this chapter.
   (2) Where a point-of-care laboratory testing device is utilized
and provides results for more than one analyte, the testing personnel
may perform and report the results of all tests ordered for each
analyte for which he or she has been found by the laboratory director
to be competent to perform and report.
   (c) As part of the overall operation and administration, the
laboratory director of a registered laboratory shall document the
adequacy of the qualifications (educational background, training, and
experience) of the personnel directing and supervising the
laboratory and performing the laboratory test procedures and
examinations. In determining the adequacy of qualifications, the
laboratory director shall comply with any regulations adopted by the
department that specify the minimum qualifications for personnel, in
addition to any CLIA requirements relative to the education or
training of personnel.
   (d) As part of the overall operation and administration, the
laboratory director of a licensed laboratory shall do all of the
following:
   (1) Ensure that all personnel, prior to testing biological
specimens, have the appropriate education and experience, receive the
appropriate training for the type and complexity of the services
offered, and have demonstrated that they can perform all testing
operations reliably to provide and report accurate results. In
determining the adequacy of qualifications, the laboratory director
shall comply with any regulations adopted by the department that
specify the minimum qualifications for, and the type of procedures
that may be performed by, personnel in addition to any CLIA
requirements relative to the education or training of personnel. Any
regulations adopted pursuant to this section that specify the type of
procedure that may be performed by testing personnel shall be based
on the skills, knowledge, and tasks required to perform the type of
procedure in question.
   (2) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to ensure that they are competent
and maintain their competency to process biological specimens,
perform test procedures, and report test results promptly and
proficiently, and, whenever necessary, identify needs for remedial
training or continuing education to improve skills.
   (3) Specify in writing the responsibilities and duties of each
individual engaged in the performance of the preanalytic, analytic,
and postanalytic phases of clinical laboratory tests or examinations,
including which clinical laboratory tests or examinations the
individual is authorized to perform, whether supervision is required
for the individual to perform specimen processing, test performance,
or results reporting, and whether consultant, supervisor, or director
review is required prior to the individual reporting patient test
results.
   (e) The competency and performance of staff of a licensed
laboratory shall be evaluated and documented by the laboratory
director, or by a person who qualifies as a technical consultant or a
technical supervisor under CLIA depending on the type and complexity
of tests being offered by the laboratory.
   (1) The procedures for evaluating the competency of the staff
shall include, but are not limited to, all of the following:
   (A) Direct observations of routine patient test performance,
including patient preparation, if applicable, and specimen handling,
processing, and testing.
   (B) Monitoring the recording and reporting of test results.
   (C) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive
maintenance records.
   (D) Direct observation of performance of instrument maintenance
and function checks.
   (E) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples, or external
proficiency testing samples.
   (F) Assessment of problem solving skills.
   (2) Evaluation and documentation of staff competency and
performance shall occur at least semiannually during the first year
an individual tests biological specimens. Thereafter, evaluations
shall be performed at least annually unless test methodology or
instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance shall be reevaluated to
include the use of the new test methodology or instrumentation.
   (f) The laboratory director of each clinical laboratory of an
acute care hospital shall be a physician and surgeon who is a
qualified pathologist, except as follows:
   (1) If a qualified pathologist is not available, a physician and
surgeon or a clinical laboratory bioanalyst qualified as a laboratory
director under subdivision (a) may direct the laboratory. However, a
qualified pathologist shall be available for consultation at
suitable intervals to ensure high quality service.
   (2) If there are two or more clinical laboratories of an acute
care hospital, those additional clinical laboratories that are
limited to the performance of blood gas analysis, blood electrolyte
analysis, or both, may be directed by a physician and surgeon
qualified as a laboratory director under subdivision (a),
irrespective of whether a pathologist is available.
   As used in this subdivision, a qualified pathologist is a
physician and surgeon certified or eligible for certification in
clinical or anatomical pathology by the American Board of Pathology
or the American Osteopathic Board of Pathology.
   (g) Subdivision (f) does not apply to any director of a clinical
laboratory of an acute care hospital acting in that capacity on or
before January 1, 1988.
   (h) A laboratory director may serve as the director of up to the
maximum number of laboratories stipulated by CLIA, as defined under
Section 1202.5.